Original scientific paper

ADVERSE DRUG REACTIONS OF PSYCOPHARMACS

Nikica Mirošević Skvrce ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Selma Arapović ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Darko Krnić ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Viola Macolić Šarinić ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Saša Žeželić ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Krešimir Bagatin ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Jelena Leventić ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia
Siniša Tomić ; Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb, Croatia

Abstract

Background: The objective of analysis of ADRs caused by drugs that pertain to the ATC group N (nervous system), as reported
to the Croatian Agency for Medicinal Products and Medical Devices for the period from March 2005 to December 2008, was to
examine the types of ADRs collected in said period, the profile of reporters and the possible impacts this could have on prescribing
this group of medicinal products in the future.
Subjects and methods: A retrospective observational study of ADRs was performed. Drugs causing ADRs were grouped
according to the ATC drug classification, and subsequently entered into a database. Data were analyzed in respect of total number,
gender, age, type, seriousness, expectedness, outcome, system organ class, suspected drug and reporter.
Results: The findings showed that 15% of all reported ADRs were caused by drugs from the ATC group N. 60% of these were
caused by drugs belonging to the ATC subgroups N05 (psycholeptics) and N06A (antidepressants). A significant increase in the
percentage of serious ADRs in the examined groups of medicinal products was observed. Analysis of expectedness showed that the
share of unexpected ADRs is very high.
Conclusion: The distribution of reporters is not satisfactory. The Agency, as regulatory authority, cannot undertake certain
measures to improve the safe use of medicinal products without having reports. Only reporting of ADRs can result in changes to
benefit all patient populations. Our joint aim should be avoiding a great number of ADRs and maintaining overall safe use of
medicinal products.

Keywords

adverse drug reaction; psycopharmacs; seriousness; safe use of medicinal products

Hrčak ID:

76360

URI

https://hrcak.srce.hr/76360

Publication date:

29.10.2010.

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